Protocol Instance History (New Design)#

Overview#

The Protocol Instance History report provides a record of a specific Protocol Instance. It includes all relevant details, associated tasks, materials, documents, states, checklists, parameters, and notes, providing traceability and supporting quality and compliance.

Warning

If you are using Enterprise Data Platform (EDP), only the Details section will be displayed.

This Stimulsoft report can be accessed through the Business Intelligence tab, in the Quality folder.

Data Source#

The report uses data from the CDM (Common Data Model) and ODS (Operational Data Store) databases, accessed through the following data sets:

Filters#

The report provides the following filters:

Instance – Identifier of the instance.
Enterprise – Name of the company.
Site – Site of the enterprise.
Facility – Specific facility within the site.

Report Sections#

The report is structured into several sections and subsections, each providing specific information related to the selected Protocol Instance.

Details#

This section provides information about the selected protocol instance. It includes the following fields:

Field	Description
Protocol	The name of the protocol instance being executed.
Product	The product associated with the protocol instance.
Root Cause	The identified cause of the issue being addressed.
Severity	The criticality level.
Resource	The resource involved in the protocol.
Inhibit Move from Step	Indicates whether movement from the current step is restricted.
Flow	The Flow associated with the protocol instance.
Inhibit Ship	Indicates whether shipment is restricted.
Facility	The facility where the protocol is applied.
Terminate on Zero Materials	Defines if the protocol instance automatically ends when no materials remain.
Step	The current Step.

In addition to these fields, Description, Problem, and Conclusions are available, providing contextual and analytical information about the protocol instance.

The Details section may also display related entities, including:

Tasks#

Name and State
Requester and Owner
Details, Progress, Completion and Results

Materials#

Name, Type
State, Owner and Quantity
Defined, Approved, Executed
Disposition and Details

Documents#

Attached Files
Type and Date

States#

A protocol instance can be in one of the following states:

Open – The state when the protocol instance is first created.
Adjust – A manually forced state change.
Change – A natural state transition based on process logic.
Close – A natural closing of the instance when completed.
Terminate – A manually forced termination of the instance.

Each state includes a set of fields that describe its characteristics:

Field	Description
Previous State	The state the protocol instance was in before the current transition.
Auto State Change Behavior	Defines if the system automatically transitions between states.
Allow Disposition	Indicates whether material disposition actions are permitted.
User	The user who performed the state change.
Allow Task Creation	Specifies if new tasks can be created in this state.
Disposition Mode	The mode used for material disposition.
Role	The user role required to perform actions in this state.
Task Creation State	The state in which tasks are automatically generated.
Disposition Requires Approval	Indicates if disposition actions in this state require approval.
Date	The date when the state change occurred.
Allow Task Release	Specifies whether tasks can be released in this state.

The States section may also display related entities, including:

Checklists#

A checklist instance contains the following information: instance and checklist name, start and end dates, state, and parameters with their values. Each checklist instance can have multiple items, such as:

User
Date of completion
Signature
Instructions
Parameters
Notes

Parameters#

Each parameter includes the name, value, and previous value.

Notes#

Each note contains the user who added it and the note content.